K152863 is an FDA 510(k) clearance for the Portable ECG Monitor. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on June 22, 2016, 266 days after receiving the submission on September 30, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K152863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2015 |
| Decision Date | June 22, 2016 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |